Back to resultsEvaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CardioPulsesTM pulsed field ablation system
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 to 75 years old;
Patients diagnosed with symptomatic paroxysmal atrial fibrillation:
At least 1 ECG or rhythm monitoring documented AF episode within 12 months prior to enrollment.
- Ineffective or intolerant of at least one antiarrhythmic drug;
- Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
Exclusion Criteria:
- AF secondary to electrolyte imbalance, thyroid disease, or reversible cause;
- Persistent or long-standing persistent AF;
- Previous surgery or catheter ablation for AF;
- Participant known to require ablation outside the pulmonary vein or in cavotricuspid isthmus region (such as atrioventricular reentrant tachycardia, atrioventricular nodalreentry tachycardia, atrial tachycardia, atrial flutter, ventricular tachycardia and Wolff-Parkinson-White syndrome);
- Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
- Previous left atrial appendage closure;
- Any myocardial infarction (MI), coronary artery bypass grafting (CABG) procedure or percutaneous coronary intervention (PCI) during the 6-month interval preceding the consent date;
- Any carotid artery stent implantation or endarterectomy within the previous 6 months;
- Left atrial diameter≥50 mm (anteroposterior);
- LVEF <40% on admission, or NYHA class III and IV;
- Presence of implanted ICD, CRT, permanent pacemaker, or any type of implantable device
- Documented active thrombus in the left atrium or atrial appendage on imaging;
- Rheumatic heart disease;
- Uncontrollable high blood pressure;
- Hypertrophic cardiomyopathy, myocardial thickening was significantly greater than or equal to 15mm;
- Frequent premature ventricular beats;
- Documented thromboembolic event (including TIA) within the past 6 months;
- Presence of intramural thrombus, tumor or other abnormality that precludes vascular access or catheter manipulation;
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gas or severe breathing difficulties;
- Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities;
- Patients with acute systemic infection;
- Serum creatinine is more than twice the upper normal limit, or have a history of kidney dialysis;
- Women who are pregnant and/or breast feeding or unable to use contraception during the trial;
- Enrollment in another clinical trial evaluating other devices or drugs during the same period;
- Life expectancy less than 12 months (such as patients with advanced cancer);
- Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.
Sites / Locations
- General Hospital of the Northern Theater of the Chinese People's Liberation Army
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experiment group
Arm Description
Patients treated with PFA catheter.
Outcomes
Primary Outcome Measures
The effectiveness of the pulsed field ablation system in the treatment of paroxysmal atrial fibrillation is evaluated by the 12-month ablation success rate of atrial fibrillation.
12-month ablation success rate of atrial fibrillation is defined by ECG data (including ECG and 24-hour dynamic electrocardiogram (Holter)) during the effective evaluation period (blanking period to the end of 12-month follow-up), without recording AF, AFL or AT (Arrhythmia monitoring device ≥ 30 seconds).
Secondary Outcome Measures
Acute isolation success rate
Acute isolation success refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
Total procedure time (defined as the total time from initial femoral venipuncture to final catheter removal), catheter dwell time (time between the pulsed field ablation catheter entering the left atrium and its withdrawal from the left atrium), pulse discharge time (The total time of delivering pulse energy through the pulsed field ablation catheter, single ablation time ablation times), total X-ray exposure time (the total time of X-ray imaging of the catheter).
Incidence of device-related or operating-related major adverse events (MAE) 3 months after surgery
Including death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve palsy, systemic circulatory embolism, pericarditis*, cardiac tamponade/perforation, atrial esophageal fistula, and severe vascular access complications.
Incidence of severe adverse events
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Incidence of device-related adverse events
Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the course of the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related, or of indeterminate relationship, to the test device.
Full Information
NCT ID
NCT05114954
First Posted
October 21, 2021
Last Updated
June 5, 2023
Sponsor
Hangzhou Dinova EP Technology Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05114954
Brief Title
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
Official Title
A Prospective, Multicenter, Single-arm Objective Performance Criteria Evaluation of the Safety and Efficacy of a Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Dinova EP Technology Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the treatment of patients with paroxysmal atrial fibrillation
Detailed Description
This study is a premarket clinical trial of a pulsed field ablation catheter system, this study evaluates the safety and effectiveness of the pulsed field ablation catheter system developed and produced by Hangzhou Dinova EP Technology Co., Ltd. in the endovascular interventional treatment of patients with paroxysmal atrial fibrillation, and provided a clinical basis for the formal application of this product in China.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experiment group
Arm Type
Experimental
Arm Description
Patients treated with PFA catheter.
Intervention Type
Device
Intervention Name(s)
CardioPulsesTM pulsed field ablation system
Intervention Description
Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.
Primary Outcome Measure Information:
Title
The effectiveness of the pulsed field ablation system in the treatment of paroxysmal atrial fibrillation is evaluated by the 12-month ablation success rate of atrial fibrillation.
Description
12-month ablation success rate of atrial fibrillation is defined by ECG data (including ECG and 24-hour dynamic electrocardiogram (Holter)) during the effective evaluation period (blanking period to the end of 12-month follow-up), without recording AF, AFL or AT (Arrhythmia monitoring device ≥ 30 seconds).
Time Frame
12 months after the ablation
Secondary Outcome Measure Information:
Title
Acute isolation success rate
Description
Acute isolation success refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.
Time Frame
20 minutes after the ablation
Title
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time
Description
Total procedure time (defined as the total time from initial femoral venipuncture to final catheter removal), catheter dwell time (time between the pulsed field ablation catheter entering the left atrium and its withdrawal from the left atrium), pulse discharge time (The total time of delivering pulse energy through the pulsed field ablation catheter, single ablation time ablation times), total X-ray exposure time (the total time of X-ray imaging of the catheter).
Time Frame
immediately after the ablation
Title
Incidence of device-related or operating-related major adverse events (MAE) 3 months after surgery
Description
Including death, myocardial infarction, stroke or transient ischemic attack (TIA), pulmonary vein stenosis, phrenic nerve palsy, systemic circulatory embolism, pericarditis*, cardiac tamponade/perforation, atrial esophageal fistula, and severe vascular access complications.
Time Frame
3 months after the ablation
Title
Incidence of severe adverse events
Description
Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
Time Frame
12 months after the ablation
Title
Incidence of device-related adverse events
Description
Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the course of the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related, or of indeterminate relationship, to the test device.
Time Frame
12 months after the ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 to 75 years old;
Patients diagnosed with symptomatic paroxysmal atrial fibrillation:
At least 1 ECG or rhythm monitoring documented AF episode within 12 months prior to enrollment.
Ineffective or intolerant of at least one antiarrhythmic drug;
Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
Exclusion Criteria:
AF secondary to electrolyte imbalance, thyroid disease, or reversible cause;
Persistent or long-standing persistent AF;
Previous surgery or catheter ablation for AF;
Participant known to require ablation outside the pulmonary vein or in cavotricuspid isthmus region (such as atrioventricular reentrant tachycardia, atrioventricular nodalreentry tachycardia, atrial tachycardia, atrial flutter, ventricular tachycardia and Wolff-Parkinson-White syndrome);
Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
Previous left atrial appendage closure;
Any myocardial infarction (MI), coronary artery bypass grafting (CABG) procedure or percutaneous coronary intervention (PCI) during the 6-month interval preceding the consent date;
Any carotid artery stent implantation or endarterectomy within the previous 6 months;
Left atrial diameter≥50 mm (anteroposterior);
LVEF <40% on admission, or NYHA class III and IV;
Presence of implanted ICD, CRT, permanent pacemaker, or any type of implantable device
Documented active thrombus in the left atrium or atrial appendage on imaging;
Rheumatic heart disease;
Uncontrollable high blood pressure;
Hypertrophic cardiomyopathy, myocardial thickening was significantly greater than or equal to 15mm;
Frequent premature ventricular beats;
Documented thromboembolic event (including TIA) within the past 6 months;
Presence of intramural thrombus, tumor or other abnormality that precludes vascular access or catheter manipulation;
Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gas or severe breathing difficulties;
Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities;
Patients with acute systemic infection;
Serum creatinine is more than twice the upper normal limit, or have a history of kidney dialysis;
Women who are pregnant and/or breast feeding or unable to use contraception during the trial;
Enrollment in another clinical trial evaluating other devices or drugs during the same period;
Life expectancy less than 12 months (such as patients with advanced cancer);
Abnormalities or diseases that the investigator considers to be excluded from the study's coverage.
Facility Information:
Facility Name
General Hospital of the Northern Theater of the Chinese People's Liberation Army
City
Shenyang
Country
China
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
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